WASHINGTON (Reuters) — Pfizer cleared the next hurdle in the race to get its COVID-19 vaccine approved for emergency use on Tuesday after the U.S. Food and Drug Administration released documents that raised no new issues about its safety or efficacy.
Pfizer and German partner BioNTech SE submitted data to the FDA last month about their coronavirus vaccine based on data showing the two-dose regimen was 95% effective against COVID-19 and had no major safety issues.
The vaccine’s efficacy data met its expectations for emergency use authorization, FDA staff said in documents released ahead of a Thursday meeting of outside experts to the FDA who will discuss whether to recommend the Pfizer shot for people aged 16 and older.
Jefferies analyst Michael Yee in research note said the documents were “very simple and straightforward, which we think will lead to approval imminently.”
The agency typically follows the recommendations of its advisory panels but is not required to do so.
“The good news is that this very important part of the process is playing out just like it should and just like it does with every other FDA regulatory review process,” said Dr. Helen Boucher, Chief of Infectious Diseases at Tufts Medical Center, in an interview with Reuters.
Data from the trial showed that the vaccine began conferring some protection to recipients even before they received the second shot. The agency’s staff noted that more data would be needed to assess the potential of a single dose shot.
The good news is that this very important part of the process is playing out just like it should and just like it does with every other FDA regulatory review process.
–Dr. Helen Boucher, Chief of Infectious Diseases, Tufts Medical Center
A two-dose vaccination was highly effective in preventing confirmed cases of COVID-19 at least seven days after the last dose, FDA staff said.
The experts will discuss whether it was reasonable to believe that the shot may be effective in preventing COVID-19, the briefing documents showed.
The documents were released on the day Britons began getting the Pfizer/BioNTech vaccine, the world’s first recipients outside of clinical trials.
The FDA staff said there was currently insufficient data to make conclusions about the safety of the vaccine in those less than 16 years of age, pregnant women and those whose immune systems were compromised.
On Thursday, a group of experts will meet to discuss an Emergency Use Authorization request for a #COVID19 vaccine. But what is an EUA? FDA Commissioner @SteveFDA explains. #AskDrHahn#FDAVaccineFactspic.twitter.com/w9jOTNu6WZ
— U.S. FDA (@US_FDA) December 7, 2020
There were a total of six deaths in Pfizer’s late-stage trial of the vaccine, with two deaths among patients receiving the vaccine and the rest in those on a placebo, the documents showed. All deaths represent events that occur in the general population at a similar rate, FDA staff said.
The FDA is expected to decide on whether to authorize the vaccine within days or weeks.
Pfizer shares rose nearly 1% to $41.66 before the bell. BioNTech’s U.S. shares were up 1.3% at $127.10.
(Reporting by Manas Mishra in Bengaluru, Rebecca Spalding and Michael Erman in New York; Editing by David Clarke and Nick Zieminski)
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